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Open Label Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas

Phase 4
18 Years
80 Years
Not Enrolling

Thank you

Trial Information

Open Label Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas

Inclusion Criteria:

- Male or female patients aged 18 - 80 years.

- Newly diagnosed or previously treated acromegalic patients.

- Lack of suppression of GH nadir to <1.0 microg/L, after oral administration of 75 g
of glucose (OGTT).

- IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age
and gender).

Exclusion Criteria:

- Requires surgery for recent significant deterioration in visual fields or other
neurological signs, which are related to the pituitary tumor mass.

- No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI).

- Symptomatic cholelithiasis.

- Unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a
history of acute myocardial infarction within the three months preceding study entry.

- Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent
hepatitis, or persistent ALT, AST, alkaline phosphatase 2 x > upper limit of normal,
or total bilirubin 1.5 x > upper limit of normal.

- Female patients who are pregnant or lactating, or are of childbearing potential and
not practicing a medically acceptable method for birth control. Medically acceptable
methods include oral birth control pills, intrauterine devices, or mechanical methods
(e.g. vaginal diaphragm, vaginal sponge or condom with spermicidal jelly). If oral
contraception is used, the patient must have been practicing this method for at least
two months prior to the screening visit and must agree to continue the oral
contraceptive throughout the course of the study, and for one month after the study
has ended.

- History of immunocompromise, including a positive HIV test result (ELISA and Western

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the use of octreotide acetate to reduce levels of GH and IGF-I in Acromegalic patients with micro (< 10 mm) and macroadenomas (> 10 mm)

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Mexico: Ethics Committee

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Acromegaly
  • microadenoma
  • macroadenoma
  • Acromegaly